2005N-0345 Drug Approvals: Circumstances under which an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter drug product
FDA Comment Number : EC1897
Submitter : Dr. Kimberly Jannarone Date & Time: 10/31/2005 04:10:53
Organization : Dr. Kimberly Jannarone
Category : Individual Consumer
Issue Areas/Comments
A. Should FDA initiate a rulemaking to codify its interpretation of section 503(b) of the action regarding when an active ingredient can be simultaneously marketed in both prescription drug product and an OTC drug product?
Emergency contraception has proven to be safe. The FDA should approve without further delay OTC sales of emergency contraception. There is no need for furthe rulemaking; just approval.
B. Is there significant confusion regarding FDA's interpretation of section 503(b) of the act?
I don't see what age has to do with anything. The approval of this drug should be clear-cut and it is not.
C. If so, would a rulemaking on this issue help dispet that confusion?
No. It is unecessary since we all know the drug is safe.
A. If FDA limited sale of an OTC product to a particular subpopulation, e.g., by making the product available to the subpopulation by prescription only, would FDA be able to enforce such a limitation as a matter of law?
No age restrictions should apply.
B. If it could, would it be able to do so as practical matter and, if so, how?
Probably not and it should not.
A. Assuming it is legal to market the same active ingredient in both a prescription and OTC product, may the different products be legally sold in the same package?
Make it available to all women and this will be moot.
B. If the two products may be lawfully sold in a single package, under what circumstances would it be inappropriate to do so?
All circumstances.
It is absolutely clear that delays in this process are motivated by a particular set of moral standards that have nothing to do with the safety of the product. The FDA should regulate the safety of drugs and leave age-restrictions that do not affect the product's effects alone.